Sana is seeking an exceptional Senior Leader to join our dynamic and growing team supporting CMC development of novel gene and cell therapy drug substances and products.
The Senior Leader of Analytical Development will oversee the establishment of analytical methods and their intensive application for product and process characterization in early development; by leveraging automation / high-throughput testing and data analysis. With a strong focus on both technical and operational excellence, this senior managerial position will play a leading role in shaping core technology platforms at Sana and the advancement of therapeutic gene and cell therapy candidates from Research into the clinic. This role represents an exciting and unique opportunity to shape the early CMC development paradigm for advance therapies. DUTIES AND RESPONSIBILITIES
The experienced leader in this role will build a world-class capability with an expert analytical team to drive product and process understanding. The leader will manage assay establishment, automation, testing operations, and data analysis across a portfolio of technologies. The leader will partner closely with process and formulation development to guide strategy and manage analytical development in order to design quality into the Phase 1 CMC packages for novel gene and cell therapies. The individual will play a key role in building out the control strategy for Sana's investigational products, and also participate in cross-functional program teams.
The successful candidate will have industrial experience managing an analytical development team for biologics/vaccines (and/or preferably gene/cell therapy), have a passion for delivering results and making an impact, an interest in technology and commitment to learning, and be an extraordinary collaborator in a dynamic setting. The ideal leader will shape strategy, build the capability, drive for operational excellence and continuous improvement, and manage a high-performing team.
QUALIFICATIONS Basic Qualifications
- Develop/oversee strategy for staged deployment of analytical methods and testing during early platform technology and CMC development. With innovation and pragmatism, accelerate the learning curve and long-term success of developing innovative new products by (1) supplying advanced analytical capabilities (with high volume and rapid turnaround time) to guide research & early CMC development, (2) enabling early and deep insights into quality attributes and process parameters, (3) critically informing the selection/optimization of product candidates, and (4) supporting the rapid translation of product candidates into the clinic.
- Build and manage a high-throughput / automated testing capability (non-GMP) to support CMC development of Sana's gene and cell therapy programs. Adapt methods for the throughput and technical demands of fast-paced early development programs. Assay families will include: biochemical, molecular biology (PCR, ddPCR), immunoassays (ELISA), cell-based (flow cytometry), and biophysical.
- Hire and manage a team of scientists to develop, operationalize, and oversee analytical methods and their application in building product insight and solving complex process and formulation development challenges.
- With a focus on technical excellence, the individual will oversee assay optimization, implementation, performance, troubleshooting, and analysis of results.
- With a focus on operational excellence, the individual will oversee the design, delivery, and continuous improvement of sample and analytical data workflows to address the needs of the business from the standpoint of: turnaround time, testing capacity, quality, and cost.
- Participate in establishment of drug substance and drug product specifications for IND, IMPD, and BLA submissions. Review/author protocols, reports, and analytical sections of regulatory submissions (IND, IMPD, BLA).
- Bachelors plus 12+ yrs or equivalent combination of education and work experience; expert knowledge of principals and concepts and is a leader; has experience managing department(s) with mid level and senior employees.
- Experience with the following methods /technologies: cellular, biochemical and molecular biological (PCR, ddPCR) methods, immunological methods (ELISA, MSD), spectroscopic and fluorescent methods, flow cytometry, HPLC, automated liquid handling, electronic notebooks.
- Prior experience leading a team in Analytical method development, testing, QC, or stability is important for success in the position.
- Must have exceptional organizational skills, preferably with advanced practical experience (+/-certification) in operational excellence or the management of complex workflows using Lean or Six Sigma.
- Solid understanding of relevant regulatory agency guidance such as FDA, ICH and EMA and hand-on experience.
- Ability to work in a fast-paced growth environment, and to prioritize work from multiple projects.
- Demonstrates a respect for others and is open to new/different ideas.
- Excellent written and verbal communication skills.
- Bachelors plus 15 yrs or equivalent combination of education and work experience; expert knowledge of principals and concepts and is a thought leader; has experience managing department(s) with senior employees.
- Organizational leader with experience managing a team of direct (and indirect) reports in technical development of CMC (analytical, process, or formulation) packages for IND/CTA submission. Demonstrated track record, broad experience, and demonstrated success in analytical sciences for characterization of biological products, associated product-related species, and process residuals/impurities.